An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)

Completed · Phase 2/Phase 3

Conditions studied: Acute Lymphoblastic Leukemia, Lymphoblastic Leukemia

In brief

This is an open-label, multicenter, dose confirmation, and PK study of JZP-458 in patients (of any age) with ALL/LBL who are hypersensitive to E. coli-derived asparaginases (allergic reaction or silent inactivation). This study is designed to assess the tolerability and efficacy of JZP-458 (only in patients who develop hypersensitivity to an E. coli-derived asparaginase), as measured by asparaginase activity.

Key facts

Study ID

NCT04145531

Run by

Jazz Pharmaceuticals

People needed

229

Starts

2019-12-27

Expected to finish

2022-07-13

Last updated by the study team

2023-11-18

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pediatric and adult patients with a diagnosis of ALL or LBL.
• Have had an allergic reaction to a long-acting E. coli-derived asparaginase OR have silent inactivation.
• Have 1 or more courses of E. coli-derived asparaginase remaining in his/her treatment plan.
• Patients must have, in the opinion of the Investigator, fully recovered from their prior allergic reaction to E. coli-derived asparaginase.

You may not qualify if…

• Have previously received asparaginase Erwinia chrysanthemi or JZP-458.
• Have relapsed ALL or LBL.
• Are concurrently receiving another investigational agent and/or treated with an investigational device at the same time as JZP-458 (within 48 hours) during Course 1 of JZP-458.
• Have a history of ≥ Grade 3 pancreatitis.
• Prior history of asparaginase-associated ≥ Grade 3 hemorrhagic event or asparaginase-associated thrombus requiring anticoagulation therapy, excluding catheter-related thrombotic events.

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Kaiser Permanente - Orange County - Anaheim Medical Center — Anaheim, California, United States
• Kaiser Permanente - Downey Medical Center — Downey, California, United States
• Kaiser Permanente - Fontana Medical Center — Fontana, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• MemorialCare Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Kaiser Permanente- Los Angeles Medical Center — Los Angeles, California, United States
• Benioff Children's Hospital Oakland — Oakland, California, United States
• Kaiser Permanente - Oakland Medical Center — Oakland, California, United States
• Children's Hospital of Orange County Main Campus - Orange — Orange, California, United States
• Kaiser Permanente - Roseville Medical Center — Roseville, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Kaiser Permanente - San Diego Medical Center — San Diego, California, United States
• University of California San Francisco Benioff Children's Hospital - Mission Bay — San Francisco, California, United States
• Kaiser Permanente - Santa Clara Medical Center — Santa Clara, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Smilow Cancer Hospital - New Haven — New Haven, Connecticut, United States
• Nemours Alfred I. Dupont Hospital for Children — Wilmington, Delaware, United States
• Children's National Health System — Washington D.C., District of Columbia, United States
• Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States
• Memorial Medical Office Centre — Hollywood, Florida, United States
• Nemours Children's Specialty Care Jacksonville — Jacksonville, Florida, United States
• Children's of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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